A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation
About this trial
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
ECOG performance status of 0 or 1.
Clear cell renal cell carcinoma (ccRCC).
Diffuse large B-cell lymphoma (DLBCL, NOS).
Disqualifiers
Untreated or progressive CNS disease unless previously treated and stable.
Other active invasive malignancy within 2 years (except certain low-risk cancers).
Prior CD70-targeting therapy, including CAR T.
ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.
Trial design
Design model
Sequential
Treatments tested in this trial
INCA036873
DrugIntravenously (IV)
Treatment groups
280 Participants
are divided into 3 treatment groupsGroup A: Part 1a Dose EscalationExperimental treatment 1 intervention
Group B: Part 1b Dose ExpansionExperimental treatment 1 intervention
Group C: Part 1c Pharmacodynamic CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
Time frame
Up to Day 282
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame
Up to approximately 2 years and 90 daysSecondary outcomes
1
Pharmacokinetics Parameter: Cmax of INCA036873
Defined as maximum observed plasma concentration of INCA036873.
Time frame
Up to approximately 2 years and 90 days2
Pharmacokinetics Parameter: Tmax of INCA036873
Defined as the time to reach the maximum plasma concentration of INCA036873.
Time frame
Up to approximately 2 years and 90 days3
Pharmacokinetics Parameter: Cmin of INCA036873
Defined as the minimum observed plasma concentration of INCA036873.
Time frame
Up to approximately 2 years and 90 days4
Pharmacokinetics Parameter: AUC(0-t) of INCA036873
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036873.
Time frame
Up to approximately 2 years and 90 daysSponsors and contacts
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Source ClinicalTrials.gov